Treatment with pimecrolimus for eczema was found unlikely to increase the risk of cancer in children, according to a post-marketing study. Findings from this study are published in JAMA Dermatology.
The PEER (Pediatric Eczema Elective Registry) study enrolled 7,457 children with a history of atopic dermatitis since 2004. After following the cohort of children for 10 years, Two leukemias, one osteosarcoma, and two lymphomas were reported as of May 2014; no skin cancers were reported. The study authors reported that the incidence of cancer overall (1.2, 95% CI: 0.5–2.8) was not statistically significant.
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Pimecrolimus, a topical calcineurin inhibitor, was approved by the Food and Drug Administration (FDA) in 2001 to treat eczema in children aged ≥2 years. Pimecrolimus contains a black box warning that describes the potential risk of malignancy associated with its use due to its similarity to oral calcineurin inhibitors used in solid-organ transplantation and spontaneous reporting of lymphomas and cutaneous malignancies.
Researchers were able to conclude that topical pimecrolimus as it was used in the PEER cohort is unlikely to increase the risk of malignancy.
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